CancerenD24 Screening as an Aid to the Clinician for the Diagnosis of Cancer (CancerenD24)

Clinical Validation Of A Diagnostic Cancerend24 Screening As An Aid To The Clinician For The Diagnosis Of Cancer In Healthy Subjects Attending The ICPC

The purpose of the researchers is to test whether the CancerenD24 index, an algorithm based on the quantitative value of CD24, CD11b, clinical and laboratory characteristics, developed in the laboratory can help in the early detection of a malignant disease in a population of healthy subjects.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Early Detection of Cancer
• Intervention / Treatment: Other: Blood-based liquid biopsy

Detailed Description

CD24 is a protein found naturally in the body and serves as a natural regulator of the immune system, in order to prevent its uncontrolled and disproportionate reaction. It is known that in a normal state the CD24protein is almost never expressed in healthy cells with the exception of the white blood cells of the blood cells in the adult person. In contrast, cancer and even pre-cancer cells express high levels of CD24. Sometimes this expression is associated with a more violent course of the cancer. Similarly, CD11b is another protein that is expressed on the surface of white blood cells and affects the migration of white blood cells and their penetration into the tissue. In addition, CD11b plays an important role in the tumor microenvironment and cancer progression. And it is used as a prognostic marker. The role and involvement of these proteins (CD24/CD11b) in various cellular processes, led our group of researchers to hypothesize that an algorithm based on CD24and CD11b protein expression on white blood cells can help in the early diagnosis of cancer and assist doctors in diagnosing this serious disease in its early stages.

The test is intended for routine use, as an aid to doctors to identify most types of cancer in earlier stages. CancerenD24 is not affected by fasting and the time of day when the blood sample is taken.

In this study, it is expected to recruit 2000 male and female subjects, who will be recruited over a period of 36 months. The experiment does not involve any treatment. During the visit to the medical center, an experienced staff member will explain the study to the patient, and after agreeing to his participation, the patient will sign an informed consent form, as is customary. After that, the same staff member will interview the patient in order to obtain demographic data and information about risk factors. After that, a venous blood sample will be taken from the patient as part of the routine blood tests taken as part of the work at the Medical Center. For this purpose, patients over the age of 40, without active cancer in the last 5 years, who come for a cancer screening (and sometimes other screenings) at the Integrated Cancer Prevention Center and the Medical Center will be recruited.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Nadir Arber, Professor; Phone Number: +972 036973561; Email: nadira@tlvmc.gov.il
• Study Contact Backup: Name: Shiran Shapira, PhD; Phone Number: +972 526842937; Email: shiran@nano24med.com

Study Locations

• Israel
  • Tel Aviv, Israel, 64239
    • Recruiting
    • Integrated Cancer Prevention Center at the Tel Aviv Sourasky Medical Center Ichilov
    • Principal Investigator: Nadir Arber, Professor
    • Contact: Nadir Arber, Professor; Phone Number: +972 036973561; Email: nadira@tlvmc.gov.il
    • Contact: Shiran Shapira, PhD; Phone Number: +972 0526842937; Email: shiran@nano24med.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy patients who attend the Integrated Cancer Prevention Center

Description

Inclusion Criteria:

1. Completion of all medical exams and questionnaires including cancer diagnoses, demographic data and other epidemiologic information
2. Willing and able to sign an informed consent
3. Age ≥40 years

Exclusion Criteria:

1. Age < 40 years
2. Pregnancy or breastfeeding
3. Any type of fever
4. Any cancer active at study entry or up to 5 years prior to study entry
5. Polyposis syndromes
6. Inflammatory bowel disease
7. Unwilling or unable to provide informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy subjects; Patients over the age of 40, without active cancer in the last 5 years, who come for a cancer screening (and sometimes other screenings) at the Integrated Cancer Prevention Center	Other: Blood-based liquid biopsy; Venous blood sample will be taken from the patient as part of the routine blood tests taken as part of the work at the Medical Center

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the CancerenD24 Screening Assay	To evaluate the "CancerenD24 screening assay" as an aid to physicians in diagnosing cancer in subjects aged 40 years and above	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and specificity of CancerenD24 versus the ground truth diagnosis	Sensitivity and specificity of CancerenD24 versus the ground truth diagnosis in subjects aged 40 years and above positive and negative predictive values of CancerenD24 versus the ground truth diagnosis in subjects aged 40 years and above	3 years
Positive and negative likelihood ratios of CancerenD24 versus the ground truth diagnosis	Positive and negative likelihood ratios of CancerenD24 versus the ground truth diagnosis in subjects aged 40 years and above	3 years
Sensitivity of the CancerenD24 versus any confirmed cancer	Sensitivity of the CancerenD24 versus any confirmed cancer during the full follow-up period of 12 months in subjects aged 40 years and above	12 months
CancerenD24 accuracy (sensitivity, specificity, PPV and NPV) measures		3 months, 6 months, 9 months, 12 months
Time to cancer diagnosis		up to 3 years

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Collaborators: Tel Aviv Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2024
• Primary Completion (Actual): September 4, 2024
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: October 22, 2024
• First Submitted That Met QC Criteria: October 23, 2024
• First Posted (Actual): October 24, 2024

Study Record Updates

• Last Update Posted (Actual): October 24, 2024
• Last Update Submitted That Met QC Criteria: October 23, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Cancer; Malignant disease; Early detection; CD24; CD11b; Venous blood sample; CancerenD24
• Other Study ID Numbers: 0365-24-TLV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No